Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
1 other identifier
interventional
40
1 country
1
Brief Summary
Evaluation if a computer-based tutorial ("MacInfo" tool) improves the patients' knowledge about intravitreal drug injections, associated risks, and the underlying diseases of treatment-naive patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 24, 2019
CompletedFirst Submitted
Initial submission to the registry
October 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFebruary 8, 2022
January 1, 2022
3.2 years
October 25, 2019
January 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of correctly answered questions between study group and control group
Patients are asked to complete a multiple choice questionnaire concerning intravitreal drug injections. Correctly answered questions will be summated. The more points the better the patients' knowledge about intravitreal drug injections.
12 months
Secondary Outcomes (1)
Usability of the MacInfo tool
12 months
Study Arms (2)
MacInfo presentation
ACTIVE COMPARATORPatient will get access to an online version of the MacInfo presentation
Placebo presentation
PLACEBO COMPARATORPatient will get access to an online version of a placebo presentation
Interventions
Eligibility Criteria
You may qualify if:
- Age 21 or older
- Patients with a need for intravitreal drug administration: wet, age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal venous occlusion
- No previous intravitreal injections
- Willingness and written informed consent to participate in the study
You may not qualify if:
- Not literate in German
- Visual acuity of less than 6/60 in the worse eye
- Severe hearing loss
- Inability to use a touch screen device (e.g. severe tremor, etc.)
- Pregnancy - for women in the reproductive age a pregnancy test is required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Findl, MD
Vienna Institute for Research in Ocular Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 25, 2019
First Posted
October 29, 2019
Study Start
October 24, 2019
Primary Completion
January 1, 2023
Study Completion
January 1, 2024
Last Updated
February 8, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share